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  1. Article ; Online: Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop.

    Mancino, Alessandra / Crea, Enrico / Messina, Monica / Ferrante, Marco / Feraco, Maria Valeria / Fazi, Paola / Vignetti, Marco

    Contemporary clinical trials communications

    2022  Volume 29, Page(s) 100992

    Abstract: Regulation (EU) No 536/2014 (Clinical Trial Regulation, CTR) offers two precious tools to academic clinical research in Italy: - The right to transfer not-for-profit clinical trials data and results for registration purposes, and co-sponsorship. - The ... ...

    Abstract Regulation (EU) No 536/2014 (Clinical Trial Regulation, CTR) offers two precious tools to academic clinical research in Italy: - The right to transfer not-for-profit clinical trials data and results for registration purposes, and co-sponsorship. - The right to transfer data reduces the time needed to make innovative therapeutical agents and therapies accessible to the patient. Co-sponsorship, on the other hand, allows the establishment of a partnership between entities with different missions, ideals and attitudes, sharing - nevertheless - the same ultimate goal: meeting the patient's medical needs. Co-sponsorship facilitates collaboration among experts, which allows knowledge sharing, thus guaranteeing, to each contributor, recognition for their own contributions to a complex activity such as a clinical trial. However, the above-mentioned Regulation poses important challenges, especially in terms of infrastructural efficiency, which is demanding, especially for those entities suffering organizational inadequacies: unfortunately, inefficiency is sometimes a structural problem in the academic clinical environment. This publication focuses on the specific innovative aspects introduced by CTR. It also highlights the possible difficulties to be addressed by their implementation.
    Language English
    Publishing date 2022-09-05
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2451-8654
    ISSN (online) 2451-8654
    DOI 10.1016/j.conctc.2022.100992
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Unlocking the potential of synthetic patients for accelerating clinical trials: Results of the first GIMEMA experience on acute myeloid leukemia patients.

    Piciocchi, Alfonso / Cipriani, Marta / Messina, Monica / Marconi, Giovanni / Arena, Valentina / Soddu, Stefano / Crea, Enrico / Feraco, Maria Valeria / Ferrante, Marco / La Sala, Edoardo / Fazi, Paola / Buccisano, Francesco / Voso, Maria Teresa / Martinelli, Giovanni / Venditti, Adriano / Vignetti, Marco

    EJHaem

    2024  Volume 5, Issue 2, Page(s) 353–359

    Abstract: Artificial Intelligence has the potential to reshape the landscape of clinical trials through innovative applications, with a notable advancement being the emergence of synthetic patient generation. This process involves simulating cohorts of virtual ... ...

    Abstract Artificial Intelligence has the potential to reshape the landscape of clinical trials through innovative applications, with a notable advancement being the emergence of synthetic patient generation. This process involves simulating cohorts of virtual patients that can either replace or supplement real individuals within trial settings. By leveraging synthetic patients, it becomes possible to eliminate the need for obtaining patient consent and creating control groups that mimic patients in active treatment arms. This method not only streamlines trial processes, reducing time and costs but also fortifies the protection of sensitive participant data. Furthermore, integrating synthetic patients amplifies trial efficiency by expanding the sample size. These straightforward and cost-effective methods also enable the development of personalized subject-specific models, enabling predictions of patient responses to interventions. Synthetic data holds great promise for generating real-world evidence in clinical trials while upholding rigorous confidentiality standards throughout the process. Therefore, this study aims to demonstrate the applicability and performance of these methods in the context of onco-hematological research, breaking through the theoretical and practical barriers associated with the implementation of artificial intelligence in medical trials.
    Language English
    Publishing date 2024-03-15
    Publishing country United States
    Document type Journal Article
    ISSN 2688-6146
    ISSN (online) 2688-6146
    DOI 10.1002/jha2.873
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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